The aim of the medical device vigilance is to guarantee health and security of patients and users. According to the current regulation, JSB experts collaborates with all the players involved in the process for the fulfilments required, managing the following activities on behalf of our clients:

  • Working as Responsible person
  • Standard Operating Procedures drafting and updating on Materiovigilance activities
  • Implementation of Post-marketing Surveillance (SSPC)
  • Support for manufacturers/and authorized representativesfor the management and notification of Incidents (including the follow-up phase and any Corrective Actions) that occurred in EU and non-EU territory
  • Support for manufacturers/ and authorized representativesfor the management of post-market and pre-markete clinical investigations

Our experience in this field allows us to give regulatory and procedural support to companies that produce and marketing medical devices, working in compliance with European Regulation (Regulation UE 2017/745). Starting from a first phase of consulting services, we follow all the steps of the CE marking, up to the commercialization and post-commercialization. In particular, we give support in:

  • Classification of DM
  • Identification of regulatory obligations for Manufacturers, Importers and Distributors of medical devices
  • Preparation and revision of Technical File
  • Certification process management for obtaining the CE mark by a Notified Body
  • Notification management to health authorities in EU countries
  • Notification of medical devices in the database/directory of the Ministry of Health
  • Preparation of advertising and, if necessary, authorization request